Phase II NICER Trial for Resectable Colon Cancer
This study is testing a new treatment approach for people with Stage I, II, or III colon cancer that can be removed by surgery. You would receive a combination of Tecentriq (an immunotherapy that helps your body's immune system fight cancer) and CAPOX chemotherapy for 12 weeks before surgery. After surgery, if your doctor thinks you're still at high risk, you might receive additional chemotherapy (mFOLFOX6 or CAPOX) for another 12 weeks. Researchers want to see how well this pre-surgery treatment shrinks the tumor, specifically if less than 10% of the cancer cells remain. To join, your tumor needs to have a specific biomarker called MSS or pMMR. The study plans to enroll 28 participants, but its current status is unclear.
- Study design
- This is a Phase II, open-label study, meaning everyone knows what treatment they are receiving. It aims to enroll 28 participants.
- What's involved
- You would receive 4 cycles of pre-surgery treatment over 12 weeks, including Tecentriq and CAPOX chemotherapy. You would also have various tests, including blood and stool collections, and imaging.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome, tumor regression, is measured 3-5 months after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05870800
Phase II Open-label Trial of Neoadjuvant Immunochemotherapy for Resectable Non-metastatic Colon cancER: NICER
Recruiting
PHASE2Ages 18–80InterventionalTreatmentBaylor College of MedicineInvestigator-initiated
~28 participants
Updated 2025-05-25 on ClinicalTrials.gov
What's tested:Tecentriq 1200 MG in 20 ML Injection + Capecitabine 1000 mg/m2 + Oxaliplatin 130 mg/m2Oxaliplatin injection 85mg/m2 + Leucovorin 400mg/m2 + 5-Fluorouracil 2400mg/m2Oxaliplatin 130mg/m2 + Capecitabine 1000mg/m2
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine the rate of tumor regression grade 1 (<10% viable cancer cells) to neoadjuvant immunotherapy and chemotherapy in resectable (non-metastatic) pMMR colon cancer, assessed in the resection specimen.
Measured over 3-5 months
Conditions
NCT05870800
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Baylor College of Medicine
Houston, Texasstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Atif Iqbal, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine
Who to contact
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Eligibility criteria
Inclusion
Signed Informed Consent Form
Age ≥18 years at time of signing Informed Consent Form
Ability to comply with the study protocol
MSS or pMMR tumor determined by local CLIA-certified PCR or IHC testing respectively.
Histologically or cytologically confirmed resectable non-metastatic adenocarcinoma of the colon.
The distal extent of the tumor must be ≥12 cm from the anal verge on pre-surgical endoscopy and/or imaging (i.e., excluding rectal adenocarcinomas warranting treatment with chemoradiation). If the patient did not undergo a pre-surgical endoscopy, then the distal extent of the tumor must be ≥12 cm from the anal verge as determined by surgical examination or pre-operative imaging.
One or more of the following high-risk features:
High CEA levels (\>5 ng/ml in non-smoker patients , \>10ng/ml in smoker patients)
Low Lymphocyte-to-monocyte Ratio (\<2.38)
Poor grade of tumor differentiation
Evidence of Lymphovascular Invasion
Evidence of Perineural Invasion
CT evidence of T3 orT4 disease w/ ≥4 cm tumor longitudinal diameter
CT evidence of regional lymphadenopathy
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment:
ANC ≥ 1.5 x 10\*9/L (1500/mL) without granulocyte colony-stimulating factor support
Lymphocyte count ≥ 0.5 x 10\*9/L (500/µL)
Platelet count ≥100 x 10\*9/L (100,000/µL) without transfusion
Hemoglobin ≥ 9 g/L (9 g/dL) Patients may be transfused to meet this criterion.
AST, ALT, and alkaline phosphatase (ALP) ≤ 2.5 x upper limit of normal (ULN)
Serum bilirubin ≤ 1.5 x ULN with the following exception:
Serum creatinine ≤1.5 x ULN or Creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula)
Serum albumin ≥ 25 g/L (2.5 g/dL)
For patients not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5 x ULN
For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
Negative hepatitis B surface antigen (HBsAg) test at screening
Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening The HCV RNA test must be performed for patients who have a positive HCV antibody test.
Negative HIV test at screening
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs, as defined below:
Exclusion
Symptomatic, untreated, or any site actively progressing metastatic disease.
History of leptomeningeal disease
Uncontrolled tumor-related pain Patients requiring pain medication must be on a stable regimen at study entry. Presence of any metastatic effusion (pleural, pericardial, ascites)
Uncontrolled or symptomatic hypercalcemia (ionized calcium \> 1.5 mmol/L, calcium \> 12 mg/dL or corrected serum calcium \> ULN)
Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis (see Appendix 11 for a more comprehensive list of autoimmune diseases and immune deficiencies), with the following exceptions:
Rash must cover \< 10% of body surface area
Disease is well controlled at baseline and requires only low-potency topical corticosteroids
There has been no occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months
History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
Active tuberculosis
Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
History of malignancy other than colon adenocarcinoma within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \> 90%), such as adequately treated carcinoma in situ of the cervix, non melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, Stage I uterine cancer or colonic polyps
Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that could impact patient safety
Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.
Prior allogeneic stem cell or solid organ transplantation
Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab
Current treatment with anti-viral therapy for HBV
Synchronous primary rectal and/ or colon cancers or history of prior invasive colon malignancy, regardless of disease-free interval.
Treatment with investigational therapy within 28 days prior to initiation of study treatment
Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \[IL-2\]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF- agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:
History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation
Known allergy or hypersensitivity to any component of the CAPOX or mFOLFOX6 chemotherapy formulations
Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months for Atezolizumab and 6 months for any chemotherapy regimen after the final dose of study treatment Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment.
What this trial measures
- Determine the rate of tumor regression grade 1 (<10% viable cancer cells) to neoadjuvant immunotherapy and chemotherapy in resectable (non-metastatic) pMMR colon cancer, assessed in the resection specimen.3-5 months
The primary outcome will be evaluated using the modified Ryan scoring system to score tumor regression grades (TRGs) in the surgical specimen. Scores will be assessed by dedicated study pathologists. Success is defined as TRG-0 or TRG-1(\<10% viable cancer cells). Efficacy-evaluable participants who do not go to surgery, perhaps due to clinical progression, will be counted as a failure.